What is a clinical trial?
A clinical trial is a research study designed to answer definitive questions about new drugs, devices, treatments or medical therapies. Clinical trials are carried out to determine if a new treatment is safe and effective. In clinical trials, the treatment option is offered to volunteers before the U.S. Food and Drug Administration (FDA) who determines if it will become available to the general public.
Why should patients participate in a clinical trial?
Patients who participate in a clinical trial have the opportunity to play an active role in their healthcare and gain access to new treatment options that are not available to the general public. Although there are no guarantees of the results, participation in trials does help to advance the science of medicine and potentially help future patients with the same problem or disease.
About Dr. Lauryssen and his experience with Clinical Trials:
Dr. Lauryssen has successfully participated 14 FDA-approved surgical device trials, 5 industry-approved clinical trials and more are pending.
Dr. Lauryssen was the first neurosurgeon to inject stem cells into a human spinal cord, as part of an FDA trial.
Dr. Lauryssen, the founder of the Institute for Advanced Spinal Research of California, and his research team have been conducting research for many years in order to improve the quality of patient care and to make a difference in patient’s lives. The bioengineering department at the Institute is looking at the cells in spinal ligament, bone marrow and synovial fluid in the hope of curing degenerative disc disease, spinal cord injury and other painful conditions of the spine.
Dr. Lauryssen was on faculty, at Washington University for 7 years where he directed the advanced neurosurgical spine program at Barnes-Jewish Hospital. He was the consulting neurosurgeon for the St. Louis RAMS and researched football player impact outcomes and spinal cord injury. Cedars-Sinai Hospital recruited him to lead the research and education departments. Seeking the freedom to quickly and effectively conduct clinical trials, he also joined Olympia Medical Center and founded the Institute for Advanced Spinal Research of California. He also founded the Lauryssen Neurosurgical Spine institute. Dr. Lauryssen relocated with his family to Austin, Texas in 2014 where he has continued to conduct several clinical trials.
Dr. Lauryssen is currently a principal investigator on 3 actively enrolling FDA clinical trials, all currently underway at St. David’s Medical Center.
Clinical Trials Actively Enrolling:
Degenerative Disc Disease (DDD) Treatment
If you suffer from lumbar DDD and require a spinal fusion to relieve your back and/or leg pain, you are not alone.
Over 400,0001 spinal fusion surgeries are performed in the US annualy.Current surgical treatment includes metal implants which hold the vertebrae together until new bone grows between them.
The CarboClear™ Pedicle Screw System is the first device to replace the metal in these implants with carbon fibers. The expected benefit of carbon fiber implants over metal implants is that the carbon fiber implant will allow accurate imaging of the spine when using MRI or CT post-operatively.
Carbon Fiber Technology in Medicine
Over the past decade, carbon fiber implants have been used clinically in the US and worldwide for orthopedic indications. The benefits of these implants include transparency in x-ray imaging and the ability to perform MRI and CT without disturbance.
This transparency allows for improved follow-up care by the medical team. To date, following a successful multi-center clinical study in Europe, the CarboClear™ carbon fiber implants have been used out of the US in over one hundred spinal procedures.
MRI image with metal screws
MRI image with carbon fiber screws
The CarboClear™ Study
The CarboClear™ clinical study will evaluate the safety and effectiveness of the CarboClear™ System for lumbar DDD patients undergoing one level spinal fusion.
The study is seeking adults with degenerative disc disease who are experiencing significant low back and/or leg pain at selected medical centers in the US. The investigators are top surgeons who specialize in treating disc disease and in spine surgery in general.
The TOPS™ System is a mechanical device that is housed between two titanium plates, which allows axial rotation, lateral bending, extension, and flexion. The implant facilitates bending, straightening and twisting movements at the affected segment of the spine while blocking excessive posterior and anterior sagittal translation.
The TOPS™ System effectively replaces the anatomical structures, such as the lamina or the facet joint that are removed from the vertebrae during the spinal decompression treatment to alleviate pain. For example, the internal metal stoppers replace the natural bony elements that served as stoppers during axial rotation. The boot and internal components take the place of the supraspinous ligament, interspinous ligament, and ligamentumflavum in their ability to help control flexion. The internal metal stoppers replace the natural bony elements that served as stoppers during axial rotation. As with spinal fusion devices, the TOPS System is anchored to the spine with four standard polyaxial pedicle screws and is implanted via a traditional posterior surgical approach. However, the TOPS System’s unique patented crossbar configuration exerts less force on the screws than typical fusion implant devices place on their fasteners. If you have symptoms of spinal stenosis, talk to your physician options about all your treatment options, and find out if Posterior Arthroplasty is the right solution for you.
Indications For Use
The TOPS™ System is designed to stabilize but not fuse the affected vertebral level following decompression surgery to alleviate pain stemming from degenerative spondylolisthesis and/or spinal stenosis.
Degenerative spondylolisthesis refers to an abnormal alignment with slippage of one spinal vertebra in relation to another that can cause pain in the lower back and legs. This condition can often occur concomitantly with a narrowing of the spinal canal, compression of the traversing nerves, and also increased abnormal movement of the two vertebrae in relation to each other. The TOPS™ System is intended to provide stabilization following decompression in skeletally mature patients with disease at one level from L3 to L5 who have not achieved sufficient symptom relief with prior conservative care.
The TOPS™ System can be used in conjunction with Premia Spine's Versalink™ Fixation System to address multi-level diseases of the spine. The Versalink™ Fixation System is intended to treat patients suffering from lumbar spinal disease at one or two adjacent levels between L1 and S1 that requires decompression and stabilization by fixation.
The TOPS™ System recreates motion in all directions – flexion, extension, lateral bending, and axial rotation. Clinically proven to provide immediate and sustained pain relief and improvement in quality of life, Premia Spine’s TOPS™ System has also been demonstrated to provide better outcomes than lumbar spinal fusion surgery for appropriate patients. The TOPS System provides three major benefits for the treatment of spinal stenosis. First, the procedure stabilizes the posterior spine and reestablishes a controlled range of movement. Second, patients regain their ability to bend, flex, walk, and enjoy the normal activities of life. Third, and most importantly, patients experience immediate and sustained pain relief. Clinical studies conducted since 2005 show the TOPS System alleviates persistent leg and low back pain for patients with moderate to severe spinal stenosis with or without spondylolisthesis (a slipped disc) and facet arthrosis (bone spurs). Do you have symptoms of spinal stenosis? Click on the testimonials to hear from people who suffered as you do. And talk to one of our doctors about all your treatment options, and find out if Posterior Arthroplasty is the right solution for you.
Providing More Flexibility in the Treatment of Spinal Stenosis and Spondylolisthesis
The TOPS™ System is a dynamic spinal implant designed to stabilize without fusing the diseased vertebral level following decompression surgery to alleviate pain stemming from spinal stenosis and/or degenerative spondylolisthesis. Spinal stenosis is a narrowing of the spinal canal, which causes a pinching of the spinal cord and nerve roots that extend from the spine to the legs. Degenerative spondylolisthesis refers to an abnormal slip of one spinal vertebra in relation to another that can cause pain in the lower back and legs. The TOPS™ System is indicated for spinal stenosis and spondylolisthesis from L3 to L5. The TOPS™ System can be used in conjunction with Premia Spine's Versalink™ Fixation System to address multi-level diseases of the spine. The Versalink™ Fixation System is intended to treat patients suffering from lumbar spinal disease at one or two adjacent levels between L1 and S1 that requires decompression and stabilization by fixation.
Pain relief is typically achieved when the surgeon removes the bone elements that press on the nerves. Upon completing the decompression, the surgeon implants the TOPS System to replace the extracted skeletal structures and stabilize the spine. With the TOPS™ System, clinicians can remove all elements pressing on nerve roots without concern for leaving enough bone for fusion to occur. Instead of permanently locking two adjacent vertebrae, clinicians allow the two vertebrae to continue moving normally with the assistance of the TOPS™ implant.
The TOPS™ System allows full motion at the operative level, while prohibiting excessive twists and turns. The result is motion preservation, optimum decompression, spine stability, and pain relief. Patients typically experience immediate pain relief post-surgery. Most patients are on their feet and walking the next day, and claim they haven't felt pain-free in years. As there is no fusion taking place in the lower back with the TOPS™ System, there are few restrictions on activity. Full recuperation varies from patient to patient. However, you can expect in most cases to experience an immediate benefit and then progressive improvement as you undergo a strengthening and rehabilitation program.